Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000821897
Ethics application status
Approved
Date submitted
4/05/2021
Date registered
28/06/2021
Date last updated
23/03/2023
Date data sharing statement initially provided
28/06/2021
Date results information initially provided
23/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle influences on the vascular endothelium for heart health
Scientific title
The association between dietary intake, arterial endothelial function and risk markers for cardiovascular disease in adults.
Secondary ID [1] 303941 0
None
Universal Trial Number (UTN)
None
Trial acronym
LIVE for Heart Health
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk 321528 0
Arterial endothelial function 321529 0
Condition category
Condition code
Cardiovascular 319281 319281 0 0
Other cardiovascular diseases
Diet and Nutrition 319282 319282 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will investigate the relationships between lifestyle behaviours (nutrition/diet quality, physical activity) and endothelial dysfunction, measured via Flow-Mediated Dilation (FMD). The risk of developing heart disease can be indicated by measuring someone’s FMD in the morning, after fasting overnight. Advanced glycation end-products (AGEs) are compounds that form naturally in our bodies when sugars attach to proteins or fats. Some people produce too many AGEs, which can increase the risk of future health problems such as diabetes and heart disease. Apart from the AGEs produced inside our body, AGEs can also enter our body when eat highly processed foods (foods that have been heated at high temperatures). Elevated AGEs in the body increase oxidative stress and cause blood vessel stiffness as a result of their crosslinking with long lived proteins. A machine called an AGE Reader is used to measure the level of AGEs in the skin by shining a UV light on your forearm. This will be used to assess associations between FMD and skin AGEs. After completion of a physical activity questionnaire, a general demographics survey and the food record participants will attend a testing session on a single occasion in the morning, following an overnight fast from 9 pm (water is allowed). On the morning of the testing session, the participants will collect a first-void, mid-stream urine sample. During the testing session, anthropometry, skin AGEs level and FMD will be measured. A fasting blood sample for analysis of metabolic and acute and chronic inflammatory markers will also be taken. The estimated time commitment required from each participant is one 90-minute testing session plus 4 days to complete the 4-day food record, physical activity and a demographics questionnaire.
Intervention code [1] 320248 0
Not applicable
Comparator / control treatment
Observational- No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327160 0
Endothelial function determined by ultrasound scans of Flow-Mediated Dilation (FMD)
Timepoint [1] 327160 0
Single time point (cross-sectional)
Primary outcome [2] 327162 0
Long-term advanced glycation end-product (AGE) deposition in skin tissue (measurement of skin autofluorescence using an AGE Reader)
Timepoint [2] 327162 0
Single time point (cross-sectional)
Secondary outcome [1] 394004 0
Bodyweight in kg will be assessed using scales and height in cm will be assessed using a stadiometer and both will be used to enable calculation of body mass index (BMI)
Timepoint [1] 394004 0
Single time point (cross-sectional)
Secondary outcome [2] 394005 0
International Physical Activity Questionnaire (IPAQ)- short form
Timepoint [2] 394005 0
Single time point (cross-sectional)
Secondary outcome [3] 394006 0
Fasting plasma glucose concentration, measured on an Indiko Analyser
Timepoint [3] 394006 0
Single time point (cross-sectional)
Secondary outcome [4] 394007 0
Fasting plasma insulin concentration, measured by ELISA.
Timepoint [4] 394007 0
Single time point (cross-sectional)
Secondary outcome [5] 394008 0
Fasting serum cholesterol (total, HDL and LDL) concentration, measured on an Indiko Analyser.
Timepoint [5] 394008 0
Single time point (cross-sectional)
Secondary outcome [6] 394009 0
Fasting serum triglyceride concentration, measured on an Indiko Analyser.
Timepoint [6] 394009 0
Single time point (cross-sectional)
Secondary outcome [7] 394010 0
Fasting blood sample will be collected for the measurement of circulating soluble receptor for AGE (sRAGE).
Timepoint [7] 394010 0
Single time point (cross-sectional)
Secondary outcome [8] 394011 0
Blood pressure using an automated blood pressure monitor (Omron).
Timepoint [8] 394011 0
Single time point (cross-sectional)
Secondary outcome [9] 394012 0
Fasting HbA1c concentration in the blood measured by assay
Timepoint [9] 394012 0
Single time point (cross-sectional)
Secondary outcome [10] 394013 0
Fasting hydration status as assessed by urine specific gravity
Timepoint [10] 394013 0
Single time point (cross-sectional)
Secondary outcome [11] 396691 0
Fasting blood sample will be collected for the measurement of inflammatory marker high sensitivity C-Reactive Protein (hsCRP)
Timepoint [11] 396691 0
Single time point (cross-sectional)
Secondary outcome [12] 396692 0
Waist circumference, measured in centimetres using a standard tape measure at the midpoint between the iliac crest and lowest rib.
Timepoint [12] 396692 0
Single time point (cross-sectional)
Secondary outcome [13] 396693 0
Body composition (fat mass, fat-free mass, total body water) will be determined using bioelectric-impedance analysis (515/514 SECA Medical Body Composition Analyser)
Timepoint [13] 396693 0
Single time point (cross-sectional)
Secondary outcome [14] 408831 0
A four day estimated food diary will be used to measure food intake
Timepoint [14] 408831 0
4-day estimation of habitual diet recorded the week prior to the testing day.

Eligibility
Key inclusion criteria
Adults
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current smokers or those who have ceased smoking within the past six months; women who are pregnant or breastfeeding; individuals who have an arteriovenous fistula or implantable cardiac defibrillator/cardiac pacemaker; people who cannot read or write English, and people who are unwilling to undergo venepuncture.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Sample size calculation: Based on alpha = 0.05, a power of 80% and an estimated correlation coefficient of 0.25 or greater between FMD and dietary macro/micronutrient intakes, 120 participants are required. Analyses: FMD analysis will be conducted according to the most recent guidelines. All data will be tested for normality using the Shapiro-Wilk test, and non-normally distributed variables will be log-transformed prior to analysis. Regression analyses will be used to explore relationships between exposure variables (age, gender, nutrient intake, biochemical marker, etc.) and the outcome variable-FMD.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/07/2021
Actual
15/07/2021
Date of last participant enrolment
Anticipated
Actual
3/10/2022
Date of last data collection
Anticipated
Actual
11/10/2022
Sample size
Target
120
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308324 0
University
Name [1] 308324 0
Monash University
Country [1] 308324 0
Australia
Primary sponsor type
Individual
Name
Dr Aimee Dordevic
Address
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 309136 0
Individual
Name [1] 309136 0
Prof Gary Williamson
Address [1] 309136 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country [1] 309136 0
Australia
Secondary sponsor category [2] 309137 0
Individual
Name [2] 309137 0
Dr Nicole Kellow
Address [2] 309137 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country [2] 309137 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308298 0
Monash University Human Research Ethics
Ethics committee address [1] 308298 0
Wellington Road
Clayton
Victoria 3800
Australia
Ethics committee country [1] 308298 0
Australia
Date submitted for ethics approval [1] 308298 0
24/03/2021
Approval date [1] 308298 0
13/04/2021
Ethics approval number [1] 308298 0
23731

Summary
Brief summary
An important marker of cardiovascular health is the flexibility of the blood vessels, which is defined as their ability to dilate and constrict. Conversely, blood vessel stiffness, caused by endothelial dysfunction, is associated with cardiovascular disease risk. This is measured using a non-invasive technique called “flow-mediated dilation” (FMD). The risk of developing cardiovascular disease can be indicated by measuring someone’s FMD in the morning, after fasting overnight.

This study will help identify dietary and lifestyle factors which may influence endothelial dysfunction (an early marker of cardiovascular disease).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110226 0
Dr Aimee Dordevic
Address 110226 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 110226 0
Australia
Phone 110226 0
+61 3 9905 2142
Fax 110226 0
Email 110226 0
[email protected]
Contact person for public queries
Name 110227 0
Ms Juanita Fewkes
Address 110227 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 110227 0
Australia
Phone 110227 0
+61 3 9902 4298
Fax 110227 0
Email 110227 0
[email protected]
Contact person for scientific queries
Name 110228 0
Dr Aimee Dordevic
Address 110228 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 110228 0
Australia
Phone 110228 0
+61 3 9905 2142
Fax 110228 0
Email 110228 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The raw data will not be shared in a data repository, registry or open source platform because it will all be made available via publications/thesis in grouped de-identied form.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.